SRIHARINI SUBRAMANIA
Augusta,USA
Summary
Biomedical professional with expertise in medical device trial inspections and maintenance of inspection-ready trial master files. Proficient in CAPA documentation and validation support, ensuring compliance and quality standards. Experienced in handling complaints and providing engineering change notice (ECN) support to uphold data integrity and audit readiness.
Overview
4
4
years of professional experience
1
1
Certification
Work History
CLINICAL RESEARCH COORDINATOR
Center for Podiatry Care
Augusta, Georgia
04.2024 - Current
- Led CAPA investigation into adhesive failure of Dexcom G6 sensor.
- Applied root cause analysis tool (5 Whys) identifying excessive humidity as a key factor.
- Implemented corrective action plan following ISO 13485, recalibrating humidity sensor to NIST standards.
- Achieved 7% reduction in defect rate through effective CAPA execution.
- Assisted with IQ/OQ/PQ activities for Scican Statim 5000, completing over 25 qualification tests.
- Supported heat distribution study using 10 calibrated thermocouples across three validation cycles.
- Conducted biological indicator testing for three pre-vacuum qualification runs, achieving 100% sterility acceptance.
- Documented over 40 pages of validation data and assisted in resolving cycle deviation
REGULATORY INTERN
Texas Biomedical Device Center
Dallas, Texas
02.2022 - 05.2023
- Executed inspection testing activities for optical leak tests, visual tests, and functional testing, achieving 90% accuracy.
- Assisted in reviewing documentation data and ensuring traceability of device inspection results.
- Maintained accurate recording and filing of inspection records within TMF and quality systems for regulatory compliance.
- Conducted operational qualification testing of CAPA tracking system, verifying automated notifications and reporting accuracy.
- Documented over 20 test results and supported investigation of one deviation during validation cycles.
- Updated user guidance to reflect new processes and contributed to validation summary report for QA review.
Education
MS - Biomedical Engineering
University of Texas at Dallas
Dallas, Texas12-2023
BE - Biomedical Engineering
PSG College of Technology
Tamilnadu, India09-2020
Skills
- CAPA management
- Root cause analysis
- Medical device validation
- FDA regulatory compliance
- Trial Master File (TMF) management
- Quality systems management
- ICH-GCP compliance
- ALCOA principles
- Informed consent process
- CSV validation
- LIMS validation
- QMS validation
- EDMS validation
- Deviation tracking software
- Microsoft Office proficiency
- 21 CFR Part 11 compliance
- 21 CFR Parts 50 & 56 compliance
- 21 CFR Part 812 compliance
- 21 CFR Part 803 compliance
- 21 CFR Part 806 compliance
- ISO standards (13485, 14971, 14155)
- GAMP 5 methodology
- Regulatory compliance (FDA, EU MDR, MHRA, Health Canada)
Accomplishments
- Managed controlled documents in Veeva Vault ensuring 100% version control compliance for IPG.
- Implemented CAPA documentation process per ISO 13485 and 21 CFR Part 820, improving audit readiness by 80% for Dexcom g6 sensor.
- Maintained TMF inspection readiness, achieving >98% document completeness and timely issue resolution.
- Supported LIMS, QMS & EDMS validation including 21 CFR part 11 compliance checks and electronic signature verification by 90%.
Certification
- GCP for Clinical Investigations of Devices, Clinical Trials with Investigational Drugs and Medical Devices
- IRB Members-Basic
- CITI Program (Biomedical Responsible Conduct of Research, Conflicts of Research)
- Medical Devices: EU Regulations (RAPS Online University)
Timeline
CLINICAL RESEARCH COORDINATOR
Center for Podiatry Care
04.2024 - Current
REGULATORY INTERN
Texas Biomedical Device Center
02.2022 - 05.2023
BE - Biomedical Engineering
PSG College of Technology
MS - Biomedical Engineering
University of Texas at Dallas